American Journal of Nephrology最新文献

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Mortality rates and a clinical predictive model for the elderly on maintenance hemodialysis: A large observational cohort study of 17,354 Asian patients 老年人维持性血液透析的死亡率和临床预测模型:一项针对 17,354 名亚洲患者的大型观察性队列研究
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-12-08 DOI: 10.1159/000535669
K. Noppakun, S. Nochaiwong, A. Tantraworasin, Jiraporn Khorana, P. Susantitaphong, A. Lumpaopong, S. Sritippayawan, V. Ophascharoensuk, C. Ruengorn
{"title":"Mortality rates and a clinical predictive model for the elderly on maintenance hemodialysis: A large observational cohort study of 17,354 Asian patients","authors":"K. Noppakun, S. Nochaiwong, A. Tantraworasin, Jiraporn Khorana, P. Susantitaphong, A. Lumpaopong, S. Sritippayawan, V. Ophascharoensuk, C. Ruengorn","doi":"10.1159/000535669","DOIUrl":"https://doi.org/10.1159/000535669","url":null,"abstract":"Background: Mortality following hemodialysis initiation may influence the decision to initiate hemodialysis in elderly patients. Our objective is to demonstrate mortality following hemodialysis initiation in elderly (≥70 years) and to derive a prediction risk score based on clinical and laboratory indicators to determine risk of all-cause mortality in patients aged ≥80 years.\u0000Methods: We identified elderly (≥70 years) who initiated maintenance hemodialysis between January 2005 and December 2016 using data from the Thai Renal Replacement Therapy Registry. The mortality rate was determined based on age categories. A predictive risk score for all-cause mortality was created for 4,451 patients aged ≥80 years by using demographics, laboratory values, and interview-based parameters. Using a flexible parametric survival analysis, we predicted mortality 3, 6 months, 1, 5, and 10 years after hemodialysis initiation.\u0000Results: 17,354 patients (≥70 years) were included, mean age 76.9±5.1 years, 46.5% male, and 6,309 (36.4%) died. Patient aged <80 years had a median survival time of 110.6 months. A 9-point risk score was developed to predict mortality in patients aged ≥80 years: age>85 years, male, body mass index<18.5 kg/m2, hemoglobin<10.0 g/dL, albumin<3.5 g/dL, substantial assistance required in daily living (1 point each), and Karnofsky Performance Score<50 (3 points). C-statistic of 0.797 indicated high model discrimination. Internal validation demonstrated good agreement between observed and anticipated mortality.\u0000Conclusions: Hemodialysis is appropriate for patients aged 70–80 years. A risk score for mortality in patients aged ≥80 years has been developed. The score is based on seven readily obtainable and evaluable clinical characteristics.","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"49 50","pages":""},"PeriodicalIF":4.2,"publicationDate":"2023-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138588323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contents Vol. 54, 2023 目录54, 2023
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-12-01 DOI: 10.1159/000535341
Adam Whaley-Connell, Wolfgang C. Winkelmayer – Baylor, Mumbai India Divya Bajpai, A. R. J. V. –. Issste, Los Mochis, Mexico Edgar V. Lerma, Joel M. Topf – St
{"title":"Contents Vol. 54, 2023","authors":"Adam Whaley-Connell, Wolfgang C. Winkelmayer – Baylor, Mumbai India Divya Bajpai, A. R. J. V. –. Issste, Los Mochis, Mexico Edgar V. Lerma, Joel M. Topf – St","doi":"10.1159/000535341","DOIUrl":"https://doi.org/10.1159/000535341","url":null,"abstract":"This study examined patients who were hospitalized in and underwent renal biopsy for new onset urinary abnormalities and/or renal impairment within 3 months of SARS-CoV-2 vaccination. We identified 17 patients. Minimal change disease was most common followed by acute tubulointerstitial nephritis and membranous nephropathy All patients underwent treatment with corticosteroids and/or immunosuppressants. Post-COVID vaccination de novo kidney disease in a newly described problem. Fenoglio describe 17 cases with a variety of kidney disease occurring within 3 months of COVID vaccination. A causal relationship cannot be proven, but the nature of the association suggests that such vaccinations might trigger an auto-immune response.","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"810 ","pages":"I - VI"},"PeriodicalIF":4.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139024770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Front & Back Matter 正面和背面事项
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-07-01 DOI: 10.1159/000531898
{"title":"Front & Back Matter","authors":"","doi":"10.1159/000531898","DOIUrl":"https://doi.org/10.1159/000531898","url":null,"abstract":"","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"54 1","pages":""},"PeriodicalIF":4.2,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47445559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Front & Back Matter 正面和背面事项
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-03-01 DOI: 10.1159/000530099
{"title":"Front & Back Matter","authors":"","doi":"10.1159/000530099","DOIUrl":"https://doi.org/10.1159/000530099","url":null,"abstract":"","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49451567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contents Vol. 53, 2022 目录2022年第53卷
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-03-01 DOI: 10.1159/000529826
M. Hammes, M. Bowman, J. Koyner, V. Perkovic
{"title":"Contents Vol. 53, 2022","authors":"M. Hammes, M. Bowman, J. Koyner, V. Perkovic","doi":"10.1159/000529826","DOIUrl":"https://doi.org/10.1159/000529826","url":null,"abstract":"Phyllis August – Weill Cornell Medicine, New York, NY, USA Atul Bali – University of Virginia, Farmville, VA, USA Vinod K. Bansal – Loyola University, Maywood, IL, USA Enrico Benedetti – University of Illinois at Chicago, Chicago, IL, USA Peter Blake – London Health Science Center, London, ON, Canada Andrew Bomback – Columbia University College of Physicians and Surgeons, New York, NY, USA Michel Burnier – University of Lausanne, Lausanne, Switzerland Alejandro R. Chade – University of Mississippi Medical Center, Jackson, MS, USA Christopher Chan – University Health Network, University of Toronto, Toronto, ON, Canada John Cockcroft – Wales Heart Research Institute, Cardiff, UK Mark E. Cooper – Monash University, Melbourne, VIC, Australia John T. Daugirdas – University of Illinois at Chicago, Chicago, IL, USA Steven Fishbane – Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA Agnes B. Fogo – Vanderbilt University Medical Center, Nashville, TN, USA Barry I. Freedman – Wake Forest School of Medicine, Winston-Salem, NC, USA Guillermo Garcia-Garcia – University of Guadalajara Health Sciences Center, Guadalajara, Mexico AJN American Journal of Nephrology","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"53 1","pages":"I - X"},"PeriodicalIF":4.2,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45383242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical Significance of Persistent Hematuria Degrees in Primary IgA Nephropathy: A Propensity Score-Matched Analysis of a 10-Year Follow-Up Cohort. 原发性IgA肾病持续血尿程度的临床意义:一项10年随访队列的倾向评分匹配分析
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-01-01 DOI: 10.1159/000529650
Ziyuan Huang, Ji Zhang, Bo Chen, Duo Li, Xiaohan You, Yin Zhou, Wenxian Qiu, Xiaokai Ding, Chaosheng Chen
{"title":"Clinical Significance of Persistent Hematuria Degrees in Primary IgA Nephropathy: A Propensity Score-Matched Analysis of a 10-Year Follow-Up Cohort.","authors":"Ziyuan Huang,&nbsp;Ji Zhang,&nbsp;Bo Chen,&nbsp;Duo Li,&nbsp;Xiaohan You,&nbsp;Yin Zhou,&nbsp;Wenxian Qiu,&nbsp;Xiaokai Ding,&nbsp;Chaosheng Chen","doi":"10.1159/000529650","DOIUrl":"https://doi.org/10.1159/000529650","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical significance of persistent hematuria degrees has not been expounded in primary IgA nephropathy (IgAN) and requires further research.</p><p><strong>Methods: </strong>From January 2003 to May 2022, a total of 684 IgAN patients with persistent hematuria were enrolled to conduct a retrospective single-center study. Patients whose hematuria degree at baseline was higher than the second tertiles of the whole were included in the high-degree hematuria cohort (Hh), and the low-degree hematuria cohort (Lh) was constructed with 1:1 matched cases from the rest according to age, gender, and estimated glomerular filtration rate (eGFR) at baseline and follow-up time. Survival was determined using the Kaplan-Meier method (K-M) and generalized linear mixed-effects model (GLMM). Risk factors for survival were determined according to the Cox proportional hazards model.</p><p><strong>Results: </strong>Both the Hh and Lh consisted of 228 cases. While the demographic data and the renal function at baseline were matched, both the K-M (p = 0.02) and GLMM (p = 0.04) proved that the prognosis of the Hh was significantly worse than that of the Lh within 10 years of follow-up. The higher persistent hematuria degree was an independent risk factor (3.93; 95% confidence interval, 1.33-11.6) associated with reaching the endpoint (eGFR decreased from the baseline ≥30% continuously or reached end-stage renal disease [ESRD]). The Hh had a significantly higher proportion of crescent (p = 0.003). The prognosis of the Hh was significantly worse than that of the Lh when accompanied by the crescent and presented an indistinct difference if the crescent was absent.</p><p><strong>Conclusions: </strong>The clinicopathologic manifestation of IgAN patients with persistent high-degree hematuria was severer, and the prognosis was worse than those with persistent low-degree hematuria.</p>","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"54 1-2","pages":"62-73"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9588307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
A 4-Variable Model to Predict Cardio-Kidney Events and Mortality in Chronic Kidney Disease: The Chronic Renal Insufficiency Cohort (CRIC) Study. 预测慢性肾脏疾病心肾事件和死亡率的4变量模型:慢性肾功能不全队列(CRIC)研究
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-01-01 Epub Date: 2023-09-06 DOI: 10.1159/000533223
Luís Mendonça, Miguel Bigotte Vieira, João Sérgio Neves, Paulo Castro Chaves, Joao Pedro Ferreira
{"title":"A 4-Variable Model to Predict Cardio-Kidney Events and Mortality in Chronic Kidney Disease: The Chronic Renal Insufficiency Cohort (CRIC) Study.","authors":"Luís Mendonça, Miguel Bigotte Vieira, João Sérgio Neves, Paulo Castro Chaves, Joao Pedro Ferreira","doi":"10.1159/000533223","DOIUrl":"10.1159/000533223","url":null,"abstract":"<p><strong>Introduction: </strong>Current prognostic models for chronic kidney disease (CKD) are complex and were designed to predict a single outcome. We aimed to develop and validate a simple and parsimonious prognostic model to predict cardio-kidney events and mortality.</p><p><strong>Methods: </strong>Patients from the CRIC Study (n = 3,718) were randomly divided into derivation (n = 2,478) and validation (n = 1,240) cohorts. Twenty-nine candidate variables were preselected. Multivariable Cox regression models were developed using stepwise selection for various cardio-kidney endpoints, namely, (i) the primary composite outcome of 50% decline in estimated glomerular filtration rate (eGFR) from baseline, end-stage renal disease, or cardiovascular (CV) mortality; (ii) hospitalization for heart failure (HHF) or CV mortality; (iii) 3-point major CV endpoints (3P-MACE); (iv) all-cause death.</p><p><strong>Results: </strong>During a median follow-up of 9 years, the primary outcome occurred in 977 patients of the derivation cohort and 501 patients of the validation cohort. Log-transformed N-terminal pro-B-type natriuretic peptide (NT-proBNP), log-transformed high-sensitive cardiac troponin T (hs-cTnT), log-transformed albuminuria, and eGFR were the dominant predictors. The primary outcome risk score discriminated well (c-statistic = 0.83) with a proportion of events of 11.4% in the lowest tertile of risk and 91.5% in the highest tertile at 10 years. The risk model presented good discrimination for HHF or CV mortality, 3P-MACE, and all-cause death (c-statistics = 0.80, 0.75, and 0.75, respectively). The 4-variable risk model achieved similar c-statistics for all tested outcomes in the validation cohort. The discrimination of the 4-variable risk model was mostly superior to that of published models.</p><p><strong>Conclusion: </strong>The combination of NT-proBNP, hs-cTnT, albuminuria, and eGFR in a single 4-variable model provides a unique individual prognostic assessment of multiple cardio-kidney outcomes in CKD.</p>","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":" ","pages":"391-398"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10170742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Epidemiology, Pathophysiology, and Clinical Perspectives of Intradialytic Hypertension. 透析中高血压的流行病学、病理生理学和临床展望。
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-01-01 Epub Date: 2023-05-12 DOI: 10.1159/000531047
Panagiotis Theofilis, Aikaterini Vordoni, Rigas G Kalaitzidis
{"title":"Epidemiology, Pathophysiology, and Clinical Perspectives of Intradialytic Hypertension.","authors":"Panagiotis Theofilis,&nbsp;Aikaterini Vordoni,&nbsp;Rigas G Kalaitzidis","doi":"10.1159/000531047","DOIUrl":"10.1159/000531047","url":null,"abstract":"<p><strong>Background: </strong>Individuals with end-stage renal disease on chronic hemodialysis (HD) may encounter numerous HD-associated complications, including intradialytic hypertension (IDHYPER). Although blood pressure (BP) follows a predictable course in the post-HD period, BP levels during the session may vary across the individuals. Typically, a decline in BP is noted during HD, but a significant proportion of patients exhibit a paradoxical elevation.</p><p><strong>Summary: </strong>Several studies have been conducted to understand the complexity of IDHYPER, but much remains to be elucidated in the future. This review article aimed to present the current evidence regarding the proposed definitions, the pathophysiologic background, the extent and clinical implications of IDHYPER, as well as the possible therapeutic options that have emerged from clinical studies.</p><p><strong>Key messages: </strong>IDHYPER is noted in approximately 15% of individuals undergoing HD. Several definitions have been proposed, with a systolic BP rise &gt;10 mm Hg from pre- to post-dialysis in the hypertensive range in at least four out of six consecutive HD treatments being suggested by the latest Kidney Disease: Improving Global Outcomes. Concerning its pathophysiology, extracellular fluid overload is a crucial determinant, with endothelial dysfunction, sympathetic nervous system overdrive, renin-angiotensin-aldosterone system activation, and electrolyte alterations being important contributors. Although its association with ambulatory BP in the interdialytic period is controversial, IDHYPER is associated with adverse cardiovascular events and mortality. Moving to its management, the antihypertensive drugs of choice should ideally be nondialyzable with proven cardiovascular and mortality benefits. Finally, rigorous clinical and objective assessment of extracellular fluid volume is essential. Volume-overloaded patients should be instructed about the importance of sodium restriction, while physicians ought to alter HD settings toward a greater dry weight reduction. The use of a low-sodium dialysate and isothermic HD could also be considered on a case-by-case basis since no randomized evidence is currently available.</p>","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"54 5-6","pages":"200-207"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10520962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mortality and Risk Factors in Very Elderly Patients Who Start Hemodialysis: Korean Renal Data System, 2016-2020. 开始血液透析的高龄患者的死亡率和危险因素:韩国肾脏数据系统,2016-2020。
IF 4.2 3区 医学
American Journal of Nephrology Pub Date : 2023-01-01 Epub Date: 2023-05-18 DOI: 10.1159/000530933
Ji Hyeon Park, Hayne Cho Park, Do Hyoung Kim, Young Ki Lee, AJin Cho
{"title":"Mortality and Risk Factors in Very Elderly Patients Who Start Hemodialysis: Korean Renal Data System, 2016-2020.","authors":"Ji Hyeon Park,&nbsp;Hayne Cho Park,&nbsp;Do Hyoung Kim,&nbsp;Young Ki Lee,&nbsp;AJin Cho","doi":"10.1159/000530933","DOIUrl":"10.1159/000530933","url":null,"abstract":"<p><strong>Introduction: </strong>The number of elderly patients with end-stage renal disease (ESRD) is increasing worldwide. However, decision-making about elderly patients with ESRD remains complex because of the lack of studies, especially in very elderly patients (≥75 years). We examined the characteristics of very elderly patients starting hemodialysis (HD) and the associated mortality and prognostic factors.</p><p><strong>Methods: </strong>Data were analyzed retrospectively using a nationwide cohort registry, the Korean Renal Data System. Patients who started HD between January 2016 and December 2020 were included and divided into three groups according to age at HD initiation (&lt;65, 65-74, and ≥75 years). The primary outcome was all-cause mortality during the study period. Risk factors for mortality were analyzed using Cox proportional hazard models.</p><p><strong>Results: </strong>In total, 22,024 incident patients were included with 10,006, 5,668, and 6,350 in each group (&lt;65, 65-74, and ≥75 years, respectively). Among the very elderly group, women had a higher cumulative survival rate than men. The survival rate was lower in patients with vascular access via a catheter than in those with an arteriovenous fistula or graft. Very elderly patients with more comorbid diseases had a significantly lower survival rate than those with fewer comorbidities. In the multivariate Cox models, old age, cancer presence, catheter use, low body mass index, low Kt/V, low albumin concentration, and capable status of partial self-care were associated with high risk of mortality.</p><p><strong>Conclusion: </strong>Preparation of an arteriovenous fistula or graft when starting HD should be considered in very elderly patients with fewer comorbid diseases.</p>","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":"54 5-6","pages":"175-183"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10520966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Ferric Citrate on Hyperphosphatemia among Chinese Patients with Chronic Kidney Disease Undergoing Hemodialysis: A Phase III Multicenter Randomized Open-Label Active-Drug-Controlled Study. 柠檬酸铁治疗接受血液透析的中国慢性肾脏病患者高磷血症的疗效和安全性:一项III期多中心随机开放标签活性药物对照研究。
IF 4.3 3区 医学
American Journal of Nephrology Pub Date : 2023-01-01 Epub Date: 2023-10-09 DOI: 10.1159/000534484
Yong Wang, Xiangmei Chen, Hanyu Zhu, Zhiyong Guo, Yibin Yang, Ping Luo, Yani He, Yan Xu, Daxi Ji, Xinlu Gao, Xiuli Sun, Changying Xing, Yu Wang, Xiaohui Wang, Shuping Zhao, Yan Guan, Hongli Lin, Aimin Zhong, Hua Shui, Fengmin Shao, Lu Lv, Yuehong Yan, Xiaokun Sun, Lei Zhang
{"title":"Efficacy and Safety of Ferric Citrate on Hyperphosphatemia among Chinese Patients with Chronic Kidney Disease Undergoing Hemodialysis: A Phase III Multicenter Randomized Open-Label Active-Drug-Controlled Study.","authors":"Yong Wang, Xiangmei Chen, Hanyu Zhu, Zhiyong Guo, Yibin Yang, Ping Luo, Yani He, Yan Xu, Daxi Ji, Xinlu Gao, Xiuli Sun, Changying Xing, Yu Wang, Xiaohui Wang, Shuping Zhao, Yan Guan, Hongli Lin, Aimin Zhong, Hua Shui, Fengmin Shao, Lu Lv, Yuehong Yan, Xiaokun Sun, Lei Zhang","doi":"10.1159/000534484","DOIUrl":"10.1159/000534484","url":null,"abstract":"<p><strong>Introduction: </strong>Hyperphosphatemia in chronic kidney disease (CKD) patients is positively associated with mortality. Ferric citrate is a potent phosphorus binder that lowers serum phosphorus level and improves iron metabolism. We compared its efficacy and safety with active drugs in Chinese CKD patients with hemodialysis.</p><p><strong>Methods: </strong>Chinese patients undergoing hemodialysis were randomized into two treatment groups in a 1:1 ratio, receiving either ferric citrate or sevelamer carbonate, respectively, for 12 weeks. Serum phosphorus levels, calcium concentration, and iron metabolism parameters were evaluated every 2 weeks. Frequency and severity of adverse events were recorded.</p><p><strong>Results: </strong>217 (90.4%) patients completed the study with balanced demographic and baseline characteristics between two groups. Ferric citrate decreased the serum phosphorus level to 0.59 ± 0.54 mmol/L, comparable to 0.56 ± 0.62 mmol/L by sevelamer carbonate. There was no significant difference between two groups (p &gt; 0.05) in the proportion of patients with serum phosphorus levels reaching the target range, the response rate to the study drug, and the changes of corrected serum calcium concentrations, and intact-PTH levels at the end of treatment. The change of iron metabolism indicators in the ferric citrate group was significantly higher than those in the sevelamer carbonate group. There are 47 (40.5%) patients in the ferric citrate group, and 26 (21.3%) patients in the sevelamer carbonate group experienced drug-related treatment emergent adverse events (TEAEs); most were mild and tolerable. Common drug-related TEAEs were gastrointestinal disorders, including diarrhea (12.9 vs. 2.5%), fecal discoloration (14.7 vs. 0%), and constipation (1.7 vs. 7.4%) in ferric citrate and sevelamer carbonate group.</p><p><strong>Conclusion: </strong>Ferric citrate capsules have good efficacy and safety in the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis. Efficacy is not inferior to sevelamer carbonate. The TEAEs were mostly mild and tolerated by the patients.</p>","PeriodicalId":7570,"journal":{"name":"American Journal of Nephrology","volume":" ","pages":"479-488"},"PeriodicalIF":4.3,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41181785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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